22
4.6 Cleaning and disinfection by machine
The washer/disinfector must have fundamentally certified ef-
fectiveness (e.g. CE marking according to DIN EN ISO 15883).
The detergent and disinfectant must be suitable for medical de-
vices made of plastic and metal and have a pH value between 5.5
and 11.
Observe the specifications from the manufacturer of the deter-
gent and disinfectant and in the chapter “Overview of validated
procedures“.
1. Place the product in a suitable rinsing basket carefully. In do-
ing so make sure the product is not touching other instru-
ments or parts of instruments.
2. Start a tested program with the following properties:
– Sufficient cleaning effect.
– Thermal disinfection: 5 to 10 minutes at 90 to 95 °C,
A
0
≥
3000.
– Final rinse with distilled or deionized water.
– Sufficient product drying (no visible fluid residues).
3. If contaminants are still visible on the product after the end
of the routine, repeat precleaning and machine cleaning and
disinfection.
4.7 Check
1. Check the product for visible damage and wear:
– Damage to the product, e.g. cracks, rough surface, splin-
tering.
– Damage to the product insulation and/or cable/connec-
tor insulation, e.g. cracks and breaks.
If damaged, do not use this product!
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